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研究生:黃詩惠
論文名稱:不同廠牌的Ceftazidime注射劑之藥品不良比較
論文名稱(外文):A comparison of adverse drug reactions of two different brands of ceftazidime injection
指導教授:張上淳張上淳引用關係科文哲助理林慧玲講師
學位類別:碩士
校院名稱:國立臺灣大學
系所名稱:臨床藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2002
畢業學年度:90
語文別:中文
論文頁數:108
中文關鍵詞:注射劑不同廠牌抗生素
外文關鍵詞:ceftazidime
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由於學名藥TatumcefÒ(ceftazidime 500mg/vial)已通過衛生署Bioavailability/Bioequivalence(BA/BE)試驗引進臺大醫院,為確定其產品品質,進行本試驗,比較不同廠牌的ceftazidime﹙即中化公司的TatumcefÒ 500mg/vial與禮來公司的KefadimÒ 500mg/vial﹚的藥品不良反應發生率,以確定TatumcefÒ的安全性,並確認兩者在療效上並無統計學上顯著的差異。
本研究為一前瞻性、隨機分配、單盲的對照研究,經過台大醫院倫理委員會同意不需簽署病患知情同意書。病房醫師依隨機變數開給不同廠牌的ceftazidime(TatumcefÒ 500mg/vial或KefadimÒ 500mg/vial),而病人未予告知使用何種廠牌藥品,如此以維持單盲條件。
主要研究終點是此兩種廠牌ceftazidime藥品不良反應發生率。次要終點是臨床反應、細菌學反應、藥品花費、劑量、療程及藥品不良反應事件發生時的處置。
本研究於民國九十年三月一日起,在台大醫院心臟外科加護病房、一般外科加護病房以及腦神經外科加護病房進行。原本預計每組至少須收納位268病人,兩組共計536人。但於實驗中期,禮來公司為確保產品品質回收Kefadim®,實驗因而被迫終止,一共收入 148 位病人。排除試驗期中給錯廠牌者後,Kefadim® 組有 68 位病人,Tatumcef® 組有 59 位病人,共127 位的資料可以作分析。
此兩組病人在基本資料、ceftazidime劑量使用的合理性以及併用的抗生素都沒有統計上的差異。研究期間Kefadim®組有13位病人發生14件藥品不良反應,Tatumcef®組有8位病人發生8件不良反應事件。藥品不良反應發生率(發生人數/總人數)分別為19.1 % 及13.6 %,兩組無統計上的差異。分就所發生的不良反應做分析,亦無統計上的差異。
所有觀察到的不良反應包括癲癇,腹瀉、紅疹、搔癢、蕁麻疹、注射部位疼痛、嗜伊性紅血球增多症、血小板減少症、alanine amino transferase(ALT)升高、alkaline phosphatase(ALP)升高、gamma-glutamyl trasnferase(g-GT)升高。其中發生率最高為皮膚紅疹(5-6 %)、血小板減少症(2-4 %)及注射部位疼痛(1-4 %),其他發生率約為1-2 %。
兩種廠牌在藥品不良反應嚴重度及藥品不良反應與ceftazidime相關性的比較方面亦無統計上的差異。
兩種廠牌在臨床反應、細菌學反應、藥品花費、劑量、療程及藥品不良反應事件發生時的處置無統計上的差異。
目錄
內容目錄……………………………………………………………….I
表目錄………………………………………………..…….………….III
圖目錄…………..………………………………………….…………..V
中英文名詞對照………………………………………………………1
中文摘要…………..………………………………………………..…..5
英文摘要…………..……………………………………………………7
第一章 前言……...……………………………………………………..9
第二章 文獻探討………………..……………………………………10
第一節 Ceftazidime 簡介…………………………………………10
一、 Ceftazidime 的藥品動態學………………………….11
二、 Ceftazidime 的劑量………………………………….14
第二節 Ceftazidime 的藥品不良反應……………………………18
一、 Ceftazidime 藥品不良反應的簡介………………….18
二、 Ceftazidime 的藥品不良反應發生率……………….18
第三節 藥品不良反應……………………………………………..23
一、 藥品不良反應定義…………………………………...23
二、 藥品不良反應與可疑藥品的相關性評估…………...23
第三章 研究目的………………..…………………………………....29
第四章 研究設計與方法……………………………………………30
第一節 研究終點………………………………………………….31
第二節 研究藥品及研究對象…………………………………….32
第三節 研究方法………………………………………………….36
一、 本研究中的各項評估項目及定義…………………..37
二、 資料收集……………………………………………...44
三、 研究樣本數的預估及數據分析……………………...45
第五章 結果………………………………………,,,…………………47
第一節 基本資料…………………………………………………..47
第二節 Ceftazidime 使用劑量的合理性評估……………………53
第三節 併用的抗生素……………………………………………..57
第四節 不同廠牌的Ceftazidime藥品不良反應…………………59
第五節 不同廠牌的Ceftazidime藥品不良反應處理方式………66
第六節 藥品不良反應與Ceftazidime的使用劑量……………….71
第七節 不同廠牌的Ceftazidime臨床反應……………………….74
第八節 不同廠牌的Ceftazidime細菌學反應…………………….76
第九節 不同廠牌的Ceftazidime的藥品花費…………………….79
第六章 討論…………………...………………………………………80
第一節 針劑是否需做生物相等性試驗…………………………..80
第二節 採用FDA藥品不良反應定義及Naranjo不良反應相關性評估法的原因……………………………………………..82
第三節 Ceftazidime使用劑量的合理性評估……………………..83
第四節 不同廠牌的Ceftazidime藥品不良反應………………….86
第五節 Ceftazidime引起血小板減少症之探討…………………..90
第六節 不同廠牌的Ceftazidime細菌學反應…………………….92
第七節 探討本試驗臨床反應多為失敗的原因…………………..95
第八節 研究限制…………………………………………………..96
第七章 結論與建議………………………………………..…………98
參考文獻………………………………………………………..……100
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